Effects of an Interdisciplinary Fitness and Social Engagement Intervention

NCT03160313 | Terminated

• 1 other identifier: 01798
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI). Primary outcomes include physical activity (PA), sleep quality, and community integration.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Social engagement; Physical Activity; Sleep Quality; Traumatic Brain Injury; Veteran

Outcome Measures

Primary Outcomes (2)

• Exercise Self-Efficacy Scale (ESES)

  ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Sleep Efficiency

  Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed. Sleep efficiency is measured by polysomnography.

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

Secondary Outcomes (5)

• Functional Capacity

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Dynamic Gait Index (DGI)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Mayo Portland Adaptability Index (MPAI-4)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Community Reintegration of Service Members (CRIS)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

Other Outcomes (3)

• California Verbal Learning Test-Second Edition (CVLT-II)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Brief Symptoms Inventory 18 (BSI-18)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

• Post-Traumatic Stress Disorder Checklist (PCL)

  Change from baseline, after intervention (week 11), and 3 months after (week 24)

Study Arms (2)

InFuSE

EXPERIMENTAL

Experimental group which will receive health education, group discussion, and supervised exercise.

Behavioral: InFuSE

Patient Education/Group Discussion

ACTIVE COMPARATOR

Active control group which will receive health education and group discussion.

Behavioral: Patient Education/Group Discussion

Interventions

InFuSE BEHAVIORAL

Each session includes a 45-minute education and group discussion. A 60-minute exercise component then completes the session. Each topic was specifically picked and tailored to benefit Veterans with TBI. The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities. The activities are included to help improve understanding and promote group discussion. The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.

InFuSE

Patient Education/Group Discussion BEHAVIORAL

Each week you will participate in a 1 hour health education class with other Veterans. Each topic was specifically picked and tailored for Veterans with TBI. These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.

Patient Education/Group Discussion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TBI of at least mild severity using criteria related to disturbance of consciousness
• Most recent TBI occurred \>1 year prior to consent process
• Medically stable with physician approval to participate

You may not qualify if:

• Unable to provide informed consent and no proxy available
• Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
• Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
• Veteran is currently active in a skilled physical therapy program.
• Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead

Study Sites (1)

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Motor Activity; Sleep Initiation and Maintenance Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: May 19, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)